10/10/2018

1

Smart Technologies to Enhance DiabetesManagement and Communication

Robert J. Rushakoff, MDProfessor of Medicine

University of California, San Franciscorobert.Rushakoff@ucsf.edu

Disclosures

None

"Each blind man perceived the elephant as something different: a rope, a wall, tree trunks, a fan, a snake, a spear..." 

Telemedicine

Central Platforms

Wearable DevicesApps

Medication/insulin Delivery

Automationinpatient/outpatient

MonitoringPersonal/central

10/10/2018

2

Diabetes And Technology Journals

JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY DIABETES TECHNOLOGY & THERAPEUTICS

National/International DM technology meetings

International Inpatient DM meetings

Diva: Romeo and JulietRomeo a six-ounce, hand-held device that

resembles a pocket calculator. Glucose Monitor Programmed to beep at set times as

reminder when to test blood sugar, take insulin, eat meals and exercise

3 month storage Records blood sugar With push of button, records insulin

doses, amount of food eaten, intensity of exercise done and the times at which all those activities took place

Juliet

device produces printouts Can send data to provider using a

telephone modem.

Robert Ratner, MD: It's not perfect for everybody. It's a lot of work, a lot of effort, and a lot of patients are unwilling to do that. And, frankly, for a lot of patients, it's not necessary.

Patient’s MD: Those who benefit most those whose diabetes is out of control and those who are newly diagnosed and need to become aware of how different things affect them.

Most people can use the system, for several months and then "graduate" to using just a diary and a simple blood sugar monitor.

Those who want to, can buy their own system - hospitals lend or rent them to patients - but the system is expensive and not always reimbursable by insurance. Romeo costs about $495; Juliet, $275.

10/10/2018

3

• The treatment with DIANET vs conventional showed a better metabolic control

• lower before breakfast: 87 +/- 6 vs 104 +/- 4 mg• Lower before lunch: 85 +/- 5 vs 104 +/- 4 mg• Lower after dinner: 102 +/- 5 vs 124 +/- 6 mg)• These results were associated with higher insulin doses in

the DIANET vs conventional treatment, and a significant reduction of hypoglycemic reaction in both group

Diva: Romeo and Juliet Chemstrip bG

When strip gone -- device worthless

Diva: Romeo and Juliet Chemstrip bG When strip gone - - device worthless Technology limited to single device

(expensive and was not covered by insurance)

Time consuming ? Who really needed it Who will pay

10/10/2018

4

Diva: Romeo and Juliet

Now 2019

Has anything changed since 1988?

10/10/2018

5

Requirements for Successful “technology” Use

Make stuff easier to do For the patient; For the MD/Nurse/Pharmacist

Integration Supports normal Workflow Scalable Sustainable Cost effective

General Concerns with Data Numbers, numbers and more

numbers: Potential to overwhelm patients,

clinicians or other care givers ? How to actually interpret all the

data and actually make real time use of the information

Stupid stuff

Wrong time on meters Wrong time on pumps

Key Issues While new technology is cool - -

Have to show some improved outcomesNot short term studies

(THINK FITBIT!!)

10/10/2018

6

Glucose Meters Generally - - still have to prick finger You get glucose value ? Remains on value for patients not on

insulin Patients on insulin - - more is better

Continuous Glucose Monitoring CGM devices continue

to improve, with interfaces that wirelessly transmit data to smartphones or a cloud-based system. As an example, the DexcomG5 mobile CGM helps caregivers to monitor their family members with diabetes and also allows physicians to monitor several of their patients at once

Glucose Meters: Abbot Freestyle Libre/Flash• Measures glucose every minute in

interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad.

• No finger prick calibration

• Disposable, water-resistant sensor can be worn on the back of the upper arm for up to 14 days

• A reader is scanned over the sensor to get a glucose result painlessly in less than one second.

• Scanning can take place while the sensor is under clothing

Glucose Meters: Abbot Freestyle Flash

10/10/2018

7

Case 1: 54 yr old man with hx kidney transplant

10/10/2018

8

So, should everyone get a Libre?

The good…

Very convenient

No fingersticks

Provides more information

Gives BG direction/trends

Cheaper than other CGMs

Slimmer size profile

The not-so-good…

No alerts or alarms

- (alert next year)

12 hour warmup per sensor

- (as of yesterday - - 1 hour)

Accuracy not as good (but consistent)

Need to carry a reader device (for now - - phone in Europe)

Getting A Freestyle Libre

Medicare coverage- Requires 4x fingerstick per day & 4x insulin injections per day

- Available via Medicare DME suppliers (eg Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now, and Mini Pharmacy)

Private insurance – Available at retail pharmacies

Cash prices at retail pharmacies (Walgreens, CVS, etc)- Reader - $70-100 (one time purchase)

- 10 day sensor - $30-45 each / $90-150/month

Next Gen CGMs

Dexcom G6 – NOW Available- 10-14 day wear

- no calibrations

- Data to phones

- Alarms to phones and friends

- Prelim data shows MARD* 8.1% with 1 calibration per day, 8.8% with no calibrations

INTERACT WITH SOME PUMPS

Dexcom / Verily CGM

Data in real time on cloud based platform

*mean absolute relative deviation

Insulin Pumps Newer pumps more user friendly Some integration with CGM Touch screen, small BUT - - still just pumps and requires a user who really

knows how to interpret data, make changes, input correct information.

10/10/2018

9

Smart Continuous Glucose Monitoring

Medtronic Pumps/CGMSmartGuard™ • low glucose suspend feature • two different

• suspension of insulin delivery when the glucose levels are predicted to hit the low limit in the next 30 minutes

• Suspension set to when the glucose levels hit the low limit.

• can automatically suspend insulin infusion for a maximum of 2 hours when sensor glucose (SG) levels are predicted to approach a pre-determined threshold and, without intervention, will resume basal insulin delivery to its pre-set rate.

Tslim/ (Dexcom)CGM

Approved for people with T1D ≥ 14 years old on >8 units of insulin/day

670G Mode Options

Full Manual - Pump settings programmed by user

Low Glucose Suspend – Pump settings programed by user. Insulin suspended if CGM value falls below threshold.

Low Glucose Prediction – Pump settings programmed by user. Insulin suspended if CGM value predicted to fall below threshold.

Closed Loop – After 2 day open loop period, system automatically adjusts basal insulin based on CGM values to target of 120 mg/dL (or 150 mg/dL during exercise). User must still manually deliver insulin during meals and ”announce” exercise. No automated correction boluses based on CGM. Suggests correction amounts based on fingerstick result (similar to current bolus wizard).

Medtronic 670G

Sensor MARD Avg

Guardian 3 - 10.55%

Enlite - 14%

Dexcom G5 - 9%

Adolescents

Adults

Median and Interquartile range of sensor glucose values midnight to midnight

Gray and dotted line = Run In

Pink and solid line = Study

Other Closed Loop Systems in Development

Tandem (t:slim x2) – Dexcom G6 (launched 2018 with autosuspend) – (automode expected 2019)

Bigfoot Biomedical – meal announcement will not require carb estimation

Beta Bionics (dual hormone – glucagon and insulin)

Insulet – Dexcom G6 (expected launch 2020)

International Diabetes Closed Loop Consortium

Diabeloop

10/10/2018

10

Diabetes Technology: 2017 Update37

What have we found with the 670G?

Greater peace of mind

Improved sleep quality

Reduced fear of hypoglycemia

More time in range

Waking up more mornings with on-target BG

Less time at extreme high and low

Less diabetes hassle

Decreased sense of regimen burden

Increased freedom to participate in activities

670G: Who does what?

Clinician-Set

- Carb ratio

- Active insulin time

- Manual mode settings

Algorithm-Determined

- Auto basal

- Insulin sensitivity factor

- Auto mode targets

Patient

- Fingerstick calibrations

- Input carbohydrates

- Announce exercise

- Input fingersticks for correctional boluses

Yes, the 670G works, but…

1. The algorithm doesn’t really “learn” you. It adapts to past 6 days.

2. The system is relatively conservative.

3. You lose a lot of flexibility.

- No manual boluses

- No extended boluses

- No temp basals

4. It chooses sensitivity factors / correction automatically. You only change carb ratios.

5. Sensors can be somewhat unreliable.

6. Some patients may lose a sense of being in control.

Bottom Line on 670G

It still takes a lot of work and patient input, but, most of the time you have to “let go”

10/10/2018

11

Here is what 670G use looks like… Bionic Pancreas

Open Artificial Pancreas System (OpenAPS)

Simplified Artificial Pancreas System (APS)

• designed to use existing approved medical devices, commodity hardware, and open source software

• designed primarily for safety, simplicity, and interoperability with existing treatment approaches as well as existing devices.

• we believe that OpenAPS can be demonstrated to be both safer and more effective than current state-of-the-art standalone insulin pump therapy, and that this can be demonstrated far more easily than for the completely novel therapy approach employed by the full APS systems that have been in clinical trials for years and are still years away from FDA approval.

10/10/2018

12

2014 Survey of Diabetes Apps

Arnhold M, et al. J Med Internet Res. 2014.

Review of top 6 apps in 2011EndoGoddess: goneBant: .99 too much

3 others gone1 still there - -out of date info

mySugr Diabetes Logbook Some Current Diabetes Apps Diabetek – (2016 – now gone) Diabetic Connect Diabetes Pilot Pro. Food database Diabetes Tracker BG Monitor Diabetes OnTrack Diabetes Diabetes in Check Glucosio

10/10/2018

13

Diabetes trackerSmartphone apps for calculating insulin dose: a systematic assessment

46 calculators that performed simple mathematical operations using planned carbohydrate intake and measured blood glucose.

59% (n = 27/46) of apps included a clinical disclaimer 30% (n = 14/46) documented the calculation formula. 91% (n = 42/46) lacked numeric input validation, 59% (n = 27/46) allowed calculation when one or more values were

missing 48% (n = 22/46) used ambiguous terminology 9% (n = 4/46) did not use adequate numeric precision 4% (n = 2/46) did not store parameters faithfully.

BMC Medicine 2015 13:106

Smartphone apps for calculating insulin dose: a systematic assessment

67% (n = 31/46) of apps carried a risk of inappropriate output dose recommendation that either violated basic clinical assumptions (48%, n = 22/46) or did not match a stated formula (14%, n = 3/21) or correctly update in response to changing user inputs (37%, n = 17/46).

Only one app, for iOS, was issue-free No significant differences were observed in issue prevalence by

payment model or platform. majority of insulin dose calculator apps provide no protection

against, and may actively contribute to, incorrect or inappropriate dose recommendations that put current users at risk of both catastrophic overdose and more subtle harms resulting from suboptimal glucose control.

BMC Medicine 2015 13:106

Platform Overload Every company has different platform Patient shows up, you can quickly pull up one but spend 10

minutes figuring out how to do downloads Multiple reports on platform and can take 10 more minutes to

find best report Would be nice to say -- everyone use this meter/pump/cgm

but insurance companies (and patients) have other ideas

Devices and software with more sophisticated algorithms that can perform pattern recognition. The question is how well that type of advancement can work.

10/10/2018

14

Glooko’s Product LineGlooko Suite of Solutions

Glooko MeterSync Device and Mobile App

For personal use

Improves self-management

Glooko Kiosk for Offices

For clinical use

Improves office workflow

MyGlooko Web App + Glooko Population

Tracker

For remote monitoring

Enables on-demand care

Glooko APIsEHR and other system integrations

Platforms: Tidepoolnonprofit company based in San Francisco, is currently building three applications

Uploader:uploading data from insulin pumps, CGMs and blood glucose meters to the platform.

Blip: online platform with numbers viewable in one shareable interface.

Nutshell: mobile app, helps patients with diabetes to better manage the meals they eat and to properly dose insulin for them.

Privacy and DM apps Initial Download Permissions

82% full network access 64% modify USB storage 30% read phone status and identity 14% find accounts on phone 11% view wifi connections 4% modify users contacts 4% view call logs

Privacy and DM apps Transmission Analysis

82% collected and shared data (insulin/glucose) with 3rd party

82% placed cookies

Sharing of sensitive Health info by apps not prohibited by HIPAA

10/10/2018

15

Privacy and DM apps Patients might mistakenly believe that

health information entered into an app is private (particularly if the app has a privacy policy), but that generally is not the case. Medical professionals should consider privacy implications prior to encouraging patients to use health apps.

Sanofi, Aetna-Inova JV target diabetes with digital therapeutic pilot program

September 25, 2017

Sanofi and Innovation Health — an insurance company jointly run by Inova and Aetna —have announced a pilot program examining the impact of digital health strategies to improve care for Type 2 diabetes patients.

The program will tap One Drop, a diabetes self-management app and Bluetooth blood sugar monitor, and Gocap, a mobile-friendly device and insulin dose management platform that emphasizes physician involvement, in an effort to improve medication adherence and patient outcomes.

Goals for “Inpatient Technology” Use Make stuff easier to do Improve glucose

control Increase in glucoses in

range Reduce hypoglycemia

Improve outcomes Infections Mortality

Reduce errors Orders Administration Documentation

Reduce Costs Reduced length of

stay Reduced rate of

readmission

Big Brother Approach

● With APEX - -Developed Daily Reports (for all adult inpatients) :– 2 or more glucoses>225 mg/dl

– Glucose <60 mg/dl

– On insulin pump

– Dx type 1 DM

● Development and implementation of virtual glucose management service.

● Based on review of the insulin/glucose chart in APEX, we remotely entered recommendations for insulin changes in a glucose management note which could be seen by all clinicians.

10/10/2018

16

TrendinhyperglycemiaratebeforeandafterintroductionoftheVirtualGlucoseManagementService

(Numberper100hospitalizedpatientswith2ormorePOCglucosereading≥225mg/dL)

Hyperglycemia rate decreased slightly (P = 0.11) throughout the 12 months prior to the introduction of vGMS and more steeply (P<0.001) during the 24 months afterwards.

Rushakoff et al. Ann Int Med May 2017

TrendinhyperglycemiaratebeforeandafterintroductionoftheVirtualGlucoseManagementService

(Numberper100hospitalizedpatientswith2ormorePOCglucosereading≥225mg/dL)

2018OCT

10/10/2018

17

The impact of the Virtual Glucose Management Service

Decrease in Hyperglycemia:

– 39% decrease in number of patients on daily hyperglycemia morning list

Decrease in Hypoglycemia:

– 38% decrease in glucoses <70 mg/dl*

– 64% decrease in glucoses <40 mg/dl* (only 15 total last year)

● Decreased by 50% number of patients with high glucoses for more than 1 day

● Decreased by 40% the time patients remain hyperglycemic

Rushakoff et al. Ann Int Med May 2017

The numbers Number of vGMS notes in past 4 years:

7000

Time to complete task: First months: 45-90 minutes Now: 20-40 minutes

Change in number of Formal Endocrinology Consults: no

Why the vGMS Worked Significant infrastructure in place Trained motivated staff Notes short, provided just in time

education Staff did not want to receive a vGMS

note - - a sign of failure!

Disagree1%

Agree38%

Strongly Agree61%

Disagree1%

Neutral22%

Agree63%

Strongly Agree14%

How often does implementation of

these recommendations

lead to improvement in your patient's

glucose?

Never1%

Sometimes11%

Often66%

Always22%

How often do you find the glucose

management note recommendations

to be helpful?

Never1% Sometimes

8%

Often49%

Always42%

The vGMS is a useful

educational tool for the

management of diabetes.

Past vGMSrecommendations have changed the way you manage diabetes in your

patients.

vGMS Resident Survey Results: 2017

Joshua A Rushakoff, Zachary Kornberg. Medical Education, in press

10/10/2018

18

“I know that for my interns, the feedback really drives their own improvements because they want to avoid getting a “glucose note" in the chart the next morning. And it works as a perfect "just-in-time" teaching mechanism to inform appropriate responses to high blood sugars for inpatients.”

Permission What Have We Learned? Physicians Can be Trained Physicians have knowledge Remain afraid to implement insulin

dosing; afraid of lows Need permission to make changes and

be aggressive Can be shamed! “Rushakoff’d”